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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / March 2026 / K260353

510(k) cleared

Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button

Arthrex, Inc. · Mar 3, 2026 · K260353

FDA cleared the Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button from Arthrex, Inc. on Mar 3, 2026 under K260353, a special 510(k). The device falls under product code HRS, Plate, Fixation, Bone, regulated at 21 CFR 888.3030 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Feb 3, 2026. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

Arthrex, Inc. has 8 other decisions in the tracker over the last 12 months: K262975 (Arthrex Beaming System), K262618 (Arthrex Spine Compression FT Screw), K262451 (Arthrex DynaNite Staples), K262357 (Arthrex Bioabsorbable PushLock Suture Anchors).

Questions & Answers

What did FDA clear under K260353?

K260353 is the FDA 510(k) for Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button, submitted by Arthrex, Inc.. FDA's decision date was Mar 3, 2026, under product code HRS (Plate, Fixation, Bone).

Who makes the Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button?

Arthrex, Inc., based in Naples, FL, is the applicant of record for K260353.

How long did the K260353 review take?

FDA received the submission on Feb 3, 2026 and issued its decision on Mar 3, 2026, 28 days later.

← All decisions in March 2026